Tianxu Han

Provide strategic, technical, and operational leadership to both PD and PE groups, overseeing the development and implementation of cell therapy manufacturing processes that have successfully advanced multiple T cell therapy programs to FDA-cleared clinical trials. Drive cross-functional collaboration as a member of the Therapeutic Products Program (TPP) leadership team, contributing to vision setting, institutional priorities, project milestones, resource planning, platform advancement, CMC strategies, and cross-functional coordination.

Cell and gene therapy process development, analytical development, and tech transfer

Led GMP manufacturing for HOPE-3 Phase III allogeneic cardiosphere-derived cell therapy for Duchenne muscular dystrophy (DMD). Oversaw strategic operations, including production planning, manufacturing execution, and facility management. Drove CMC/Manufacturing readiness to support BLA planning and commercialization pathways.

• Leading a multi-disciplinary team to manufacture GMP grade cell therapy including CMV-specific CAR-T cell therapy at City of Hope’s Center for Biomedicine and Genetics and GMP grade CMV/CD19 product at Cellular Therapies Production Center at City of Hope. • Coordinate with QA team, QC teams, and regulatory affairs group to establish project plans, execute, monitor and track program progress. • Preparing CMC for IND submission. • Supporting IND-enabling studies for CMV/CD19 and CMV/HIV CAR T cell therapy. • Production development and Process development lead for CMV/CD19 and bi-specific CMV/HIV CAR-T cell therapy. • Leading technology transfer from small-scale process development to large-scale GMP manufacturing, including writing all SOPs for CAR-T cell manufacturing. • Develop and optimize analytical assays for QC testing and characterization of the cell products needed for product release. • Troubleshooting GMP production process challenges. • Mentoring and training senior Scientists and Research Associates in the teams. • Participate in correlative studies for Hematopoietic Stem Cell therapy in the clinical trial.

• Developed and optimized antigen-specific-TCR T cell isolation protocol. • Isolated NY-ESO-1, HPV-E6, HPV-E7, and EBV specific TCR T cells. • Identified and cloned several novel TCRs specific to HPV-E6, HPV-E7, and EBV antigens using a single-cell TCR cloning technique. • Functional validation of HPV-E6, HPV-E7, and EBV specific TCRs in vitro. • Optimized protocols for antigen presentation on APCs.

• In charge of project design, management, operations, results analysis, and project reports. • In charge of product development, generating new SOPs and/or revising the existing SOPs. • Responsible for mentoring and training Junior Scientists and Research Associates in the company. • In responsible charge of dozens of CRISPR/Cas9-based genome editing projects contracted from Vertex, Sanofi, Pfizer, uniQure, and other notable pharmaceutical companies. Designed and executed gene-editing to knock-out or knock-in various genes in human iPSCs, aiming at developing gene-therapy potential cells. • In responsible charge of hESC/iPSCs direct differentiation projects, including differentiation of Hematopoietic Stem and Progenitor Cells (HSPC), T cells, Macrophage, Neural Stem Cells (NSC), Motor Neuron (MN), Oligodendrocyte Progenitor Cells (OPC), etc. • In responsible charge of various primary cell (T cells, B cells, macrophage, various types of endothelial cells and epithelial cells, etc) isolation, characterization, and cell product manufacturing. • Established a real-time imaging platform to quantify phagocytosis based on Incucyte system. • Supported generation of hundreds of stable cell lines expressing various mutations of ABC and CFTR, respectively

• Wrote research project applications, proposals and manuscripts. • Mentored and trained graduate students and technicians in the lab. • Identified a transcription factor as an HSC regulator and studied the mechanism by which it regulates HSC self-renewal and differentiation using biochemical and genetic approaches, as well as mouse transplantation model. • Designed and constructed various lentiviral and retroviral vectors for knock-down, knock-out, and over-expressing genes in HSCs. • Performed human HSC expansion ex vivo using synthesized Eupalinilide E. • Conducted a genome-wide screen using GeCKO v2 Human CRISPR Knockout Pooled Library to identify host factors in T cells required for HIV infection.

• Developed platforms for high-titer lentivirus production, ESCs transduction, and differentiation of ESCs towards HSPCs in vitro. • Conducted a genome-wide RNAi screen in ESCs with lentiviral shRNA pooled library to identify genes and networks regulating HSC differentiation from ESCs/iPSCs in vitro and identified 12 groups of genes that are required during distinct stages of HSC development using high-throughput sequencing and bioinformatic analysis. • Validated the candidate genes that are important for distinct stages of HSPC development in vitro; further studied the function of four HSPC specification required genes, Ap2a1, Lrsam1, Mettl22, and Hal in zebrafish and in human CD34+ cells.